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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K190303
Device Name AirSeal
Applicant
ConMed Corporation
525 French Road
Utica,  NY  13502
Applicant Contact Lisa Anderson
Correspondent
ConMed Corporation
525 French Road
Utica,  NY  13502
Correspondent Contact Lisa Anderson
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received02/12/2019
Decision Date 03/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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